SpicyIP Tidbit: Delhi High Court Denies Grant of Interim Injunction to Bristol Myers Squibb


Earlier this year in March, we had blogged on the dispute between Bristol Myers Squibb (BMS) and Ranbaxy, where the Delhi High Court refused to grant an ex parte interim injunction against Ranbaxy. Instead, the Court issued notice to Ranbaxy and subsequently arguments on the application for interim injunction were heard.
Yesterday, the Economic Times reported that the Court has rejected BMS’s application for interim injunction against Ranbaxy’s generic version of the drug Baraclude (Entecavir), which is used to treat Hepatitis B. The drug was granted by the Mumbai Patent Office in 2008 pursuant to an application filed in 2001 and has reportedly earned BMS a whopping $439 in the six months preceding June 2010.
The Court held that BMS’s patent on Entecavir appeared prima facie “vulnerable” in addition to bringing in the now-standard “public interest” angle into the picture. The Court held that patients of Hepatitis B shouldn’t be deprived of access to Ranbaxy’s low-cost generic version during the pendency of the suit. Reportedly, generic versions of Baraclude cost less than half of BMS’s tablets of 0.5 and 1mg dosages.
However, the Court has asked Ranbaxy to maintain an account of its sales.
This decision is probably a shot in the arm for Cadila and Natco which too have launched their respective generic versions of Baraclude.
We welcome information and opinion from our readers on the case. 

5 comments.

  1. AvatarAnonymous

    Public interest in this case may be tackled as below:

    If it is affordability – BMS may attempt to supply entecavir at the same price as provided other generics.

    If it is accessibility in India – it can be easily produced in India by BMS via contract manufacturing.

    Jai Hind…

    Reply
  2. AvatarKshitij Malhotra

    Interestingly, this comes after Madras HC granted an “ex-parte injunction” to Roche against Matrix few days back. Very distinct views taken by two High Courts that seem to be at the centre of patent litigation in this country.

    Another article (http://processandproduction.pharmaceutical-business-review.com/news/ranbaxy_wins_baraclude_patent_case_against_bristolmyers_squibb_100922/) reports: Justice Sunil Gaur opined that BMS only had a product-by-process patent on its drug and hence is vulnerable.

    A quick search on the patent office website reveals patent number 213457 relating to a composition similar to Baraclude. The patent seems to cover entecavir (generic name for Baraclude) supported on a carrier. However, there seems to be no product-by-process claims or process claims in the patent.

    Reply
  3. AvatarJ.Sai Deepak

    Dear Kshitij,
    Thanks for the additional information. But I hope the Court did not hold the patent vulnerable merely because it is a product-by-process patent, if at all it is one. A product-by-process claim still remains a product which the patentee chooses to characterize using the process. Of course, this kind of characterization is not used generally unless the product cannot be described in any other manner. I would like to go through the judgment once, but I fear it may not have been a reasoned one.

    Bests,
    Sai.

    Reply
  4. AvatarKshitij Malhotra

    Absolutely Deepak. Will be very interesting to know the grounds on which the petition would have been dismissed. Do you have a copy of the judgment? If yes, please post a web link for our reference.

    Reply

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